Neulastim

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Neulastim

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Neulastim

Quick Facts

Property Description
Active ingredient Pegfilgrastim
Form Solution for Injection
Pharmacological class Hematopoietic Growth Factor (G-CSF Analog)
General purpose Prevention of severely low white blood cell counts
Origin Biologic (Recombinant, Pegylated Protein)

What Type of Medicine is Neulastim (Pegfilgrastim)?

Neulastim is a prescription-only medication containing the active ingredient Pegfilgrastim, which is classified as a Hematopoietic Growth Factor and a Granulocyte Colony-Stimulating Factor (G-CSF) analog. This biologic agent is designed to support the body's immune system by enhancing the production of specific infection-fighting cells. Pegfilgrastim is a man-made form of a protein that stimulates the growth of white blood cells. Its mechanism involves an effect on progenitor cells in the bone marrow.

As a G-CSF analog, Neulastim belongs to a pharmacological class that mirrors the action of natural growth factors found in the body. The medication is produced via recombinant biotechnology and is managed as a complex therapeutic protein.

Composition and Form: The Biologic Nature of Pegfilgrastim

The active substance Pegfilgrastim is a modified biologic substance, derived from its precursor filgrastim, via a chemical process called pegylation. This modification involves the covalent binding of the protein to a molecule called polyethylene glycol (PEG). The drug is typically supplied as a clear, aqueous solution for injection, often provided in a pre-filled syringe for subcutaneous administration.

This unique composition is critical because the addition of PEG gives Pegfilgrastim a sustained release profile, allowing it to remain active for an extended period after injection. This design results in a long half-life, making it suitable for single-dose administration per chemotherapy cycle. This sustained action provides a unique differentiating factor compared to its non-pegylated counterpart.

General Purpose: Supporting the Immune System

The essential benefit of Neulastim is the stimulation of neutrophil production, which are the white blood cells crucial for fighting bacterial infections throughout the body. The medication is utilized in supportive care. A typical scenario involves using the drug in a prophylactic context to help prevent the development of a severely low white blood cell count, a condition known as neutropenia, particularly following myelosuppressive therapies. By maintaining adequate levels of these infection-fighting neutrophils, the drug aims to fortify the patient's immune defenses.

Regulatory References

  1. U.S. National Library of Medicine

What side effects are possible with Neulastim?

Possible Side Effects and Safety Information

The official safety profile of Neulastim (Pegfilgrastim) categorizes potential reactions based on their frequency as documented in regulatory sources.

Very Common and Common Reactions

The most frequently documented adverse reaction is bone pain, officially classified as very common (ge 1/10). Other effects classified as common (ge 1/100 to < 1/10) include headache, general musculoskeletal pain, leukocytosis (increased white blood cell count), and minor changes like transient elevations in liver function tests.

Frequency Classification Key Adverse Reactions
Very Common Bone pain
Common Headache, Musculoskeletal pain, Leukocytosis, Thrombocytopenia

Serious Adverse Reactions and Systemic Concerns

Regulatory documents list several serious, though uncommon or rare, adverse reactions affecting multiple system-organ classes. These include conditions affecting the blood, lungs, and skin, such as splenic rupture, Acute Respiratory Distress Syndrome (ARDS), Capillary Leak Syndrome (CLS), and severe hypersensitivity reactions including anaphylaxis.

Less frequently, conditions like Aortitis (inflammation of the aorta) and severe skin reactions like Stevens-Johnson syndrome (SJS) have been documented.

Population-Specific and Contextual Safety Notes

Specific warnings are noted for defined populations. Patients with underlying sickle cell disorders are subject to an explicit safety statement regarding the risk of severe and sometimes fatal sickle cell crises. Furthermore, the use of Pegfilgrastim in patients receiving chemotherapy and/or radiotherapy has been associated with the risk of developing Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). The official label also notes a transient rise in white blood cell counts, which typically peaks 24 to 48 hours after administration, consistent with the drug's intended action.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information for Neulastim

The information regarding overexposure to Neulastim (Pegfilgrastim) is based strictly on documentation from government regulatory agencies, focusing on documented manifestations and mandated emergency actions.

Documented Overdose Profile

Element Factual Data from Official Regulatory Sources
Documented Presentations Single doses up to 300 mug/kg have been administered in clinical studies without reports of serious adverse reactions.
Physiological Effect The principal effect of overexposure is an exaggerated pharmacodynamic response, resulting in Leukocytosis (abnormally high white blood cell count).
Required Action Management involves standard symptomatic treatment and supportive care; no specific antidote is known.

When to Seek Urgent Medical Attention

The need for urgent medical help is dictated by the physiological effects of the medicine, as explicitly stated in the regulatory documentation. The drug must be immediately discontinued and medical attention sought if the patient's leukocyte count exceeds 50 imes 10^9/l after the expected nadir. Furthermore, regulatory labeling cites a potential overdose risk if the On-body Injector syringe is used for manual subcutaneous injection. Close monitoring of the complete blood count is essential, as the continued presence of excessive white blood cells may pose a risk.

Therapeutic Uses of Neulastim

What Neulastim Treats: Main Uses and Benefits

The purpose of Neulastim (Pegfilgrastim) is to provide critical supportive care by addressing the risk of infection and complications that arise when treatments for other serious conditions damage the immune system. The medication is primarily relevant for two distinct areas of use related to severe immune system depletion.

Neulastim is commonly used in oncology supportive care to mitigate the hematological toxicity caused by myelosuppressive anti-cancer drugs, preventing the onset of severe neutropenia. It is applied across domains where additional symptomatic support is needed to decrease the incidence of febrile neutropenia (fever combined with low white blood cells), a complication that generally involves acute infection risk. By supporting the production of infection-fighting white blood cells, Neulastim contributes to continuity in the patient’s overall care plan, helping to ensure the treatment schedule can remain on track. In a distinct, high-acuity context, the medication is applied to individuals acutely exposed to myelosuppressive doses of radiation, a clinical situation relevant to the Hematopoietic Subsyndrome of Acute Radiation Syndrome (H-ARS), to support patient outcomes in situations where severe immune depletion has occurred.


Quick Fact: Relief for Infection Risk

Context Benefit Provided
Primary Condition Severe neutropenia
Symptom Managed Risk of infection, febrile episodes
Clinical Scenario Prophylactic use during chemotherapy cycles
Patient Benefit Supports maintenance of functional stability

Regulatory References

  1. NIH DailyMed official label

Eligibility and Restrictions for Use

Who Can and Cannot Use Neulastim?

The official eligibility profile for Neulastim (Pegfilgrastim) is strictly defined by government regulatory agencies and sets clear boundaries for its use based on patient population.

Contraindications and Exclusions

Use is absolutely forbidden in patients with a history of serious allergic reactions (including anaphylaxis) to pegfilgrastim, filgrastim, or any component in the formulation. The medicine is not recommended for patients diagnosed with Myelodysplastic Syndromes (MDS) or Chronic Myelogenous Leukaemia (CML), as safety and efficacy have not been established in these myeloid conditions.

Restricted and Conditional Use

Patients with Sickle Cell Trait or Disease require caution and close monitoring during use due to the documented risk of severe sickle cell crises. Use during pregnancy or breastfeeding is not recommended by regulatory agencies due to insufficient human data on potential effects.

Age-Group Eligibility

Neulastim is approved for use in adults. For the pediatric population, safety and efficacy have generally not yet been established (EU labeling). Furthermore, the standard single-dose syringe is not designed for administration to pediatric patients weighing less than 45 kg due to complex weight-based dosing requirements (US labeling).

What should I know about interactions with other medicines?

Interactions with other medicines and products

The most significant and officially documented interaction for Neulastim (pegfilgrastim) relates to its required timing of administration concerning cytotoxic chemotherapy.

Pegfilgrastim stimulates the production of rapidly dividing myeloid cells. Administering this medication too close to chemotherapy could make these newly stimulated cells more vulnerable to the cytotoxic (cell-killing) effects of the chemotherapy agent, potentially increasing myelosuppression. Therefore, a mandatory procedural restriction is in place:

  • Do not administer Neulastim in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Clinical data has indicated that Neulastim can be safely given 14 days before chemotherapy. The requirement to wait at least 24 hours after chemotherapy is a critical measure to mitigate this interaction risk.


Other Interacting Products and Substances

Substance Category Documented Interaction Status
Antimetabolites (e.g., 5-fluorouracil) Concomitant administration has shown the potential to potentiate myelosuppression in animal models.
Lithium Potential for interaction has not been specifically investigated; lithium also promotes neutrophil release, but there is no evidence that a harmful interaction would occur.
Other Haematopoietic Growth Factors/Cytokines Possible interactions have not been specifically investigated.
Chemotherapy with Delayed Myelosuppression (e.g., nitrosoureas) The safety and effectiveness of Neulastim have not been evaluated in patients receiving these agents.

In general, specific drug-drug interaction studies have not been widely performed; however, clinical trials have not indicated a broader interaction profile with other medicines.

Mechanism of Action

Neulastim (pegfilgrastim) is a long-acting analog of human Granulocyte-Colony Stimulating Factor (G-CSF). Its primary site of action is the hematopoietic system within the bone marrow, where it selectively targets cells expressing the G-CSF receptor.

G-CSF Receptor Activation

Neulastim functions as a receptor agonist, binding to specific G-CSF receptors on the surface of myeloid progenitor cells and mature neutrophils. This binding initiates multiple intracellular signaling pathways, notably the JAK/STAT, PI3K-AKT, and MAPK/ERK cascades. Activation of these pathways drives the signaling sequence required for cellular growth, differentiation, and maturation.

Modulation of Neutrophil Lineage

The drug's effect extends to stimulating the proliferation and differentiation of granulocyte precursor cells, accelerating their development, and enhancing the survival of mature neutrophils. The extended duration of action is conferred by pegylation, which reduces renal clearance. Furthermore, the binding of the drug to its receptor on circulating mature neutrophils facilitates a self-regulatory receptor-mediated clearance process, contributing to the modulation of neutrophil concentration. The overall mechanism results in enhanced neutrophil mobilization and a transient increase in circulating neutrophil numbers.

Dosage and Administration Information

How to Use Neulastim (Pegfilgrastim) — Official Administration Guidelines

Neulastim is administered by subcutaneous injection only. Instructions for use emphasize strict adherence to timing and preparation protocols to ensure proper dosing.


Dosing and Timing

Context Dosing Schedule Timing Constraint
Myelosuppressive Chemotherapy A single 6 mg dose per chemotherapy cycle for patients ge 45 kg. Do not administer from 14 days before to 24 hours after cytotoxic chemotherapy.
Acute Radiation Syndrome Two doses of 6 mg each, administered one week apart for patients ge 45 kg. The first dose must be given as soon as possible after suspected radiation exposure.

For pediatric patients weighing less than 45 kg, a weight-based dosing schedule applies, requiring careful calculation and measurement.


Preparation and Administration

  1. Preparation: Remove the prefilled syringe or vial from the refrigerator and allow it to warm to room temperature (68F to 77F) for a minimum of 30 minutes. Do not shake the syringe or warm it using external heat sources.
  2. Inspection: Visually inspect the solution for discoloration or the presence of particulate matter. If either is observed, the product must not be used.
  3. Delivery Method: Administration is typically via a manual prefilled syringe into the thigh, abdomen (excluding the area 2 inches around the navel), or upper arm/buttock by a caregiver.
  4. On-body Injector (OBI): An OBI device may be used, which is applied by a healthcare provider and automatically delivers the dose approximately 27 hours after application.
  5. Missed Dose: If a dose is missed or an OBI fails to deliver the full dose, patients must contact a healthcare professional immediately for instruction on administering a replacement dose.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Clinical studies for Neulastim (pegfilgrastim) primarily investigate its role in managing chemotherapy-induced neutropenia (CIN). The medication is a long-acting form of a granulocyte colony-stimulating factor (G-CSF) that stimulates the production of neutrophils, a type of white blood cell essential for fighting infection.


Efficacy and Outcomes in CIN

Trials compared a single dose of Neulastim per chemotherapy cycle with multiple daily doses of its parent compound, filgrastim. The main measure of effectiveness was the Duration of Severe Neutropenia (DSN), defined as the number of consecutive days with a dangerously low neutrophil count. The research reported the following findings in breast cancer patients receiving myelosuppressive chemotherapy:

  • Non-Inferiority: Neulastim was reported to be non-inferior to daily filgrastim in reducing the duration of severe neutropenia (DSN) during the first chemotherapy cycle.
  • Incidence of Febrile Neutropenia (FN): Clinical evidence suggests Neulastim is associated with a decrease in the incidence of infection, as manifested by febrile neutropenia, compared to no stimulating factor use.

Safety Profile and Reported Adverse Events

Across multiple studies, the safety profile of Neulastim was comparable to that of filgrastim. The most frequently reported adverse event is bone pain, which was often mild-to-moderate and manageable.

Less common, but serious, adverse events that have been reported in the post-market setting or in association with G-CSF class drugs include:

System Condition Reported
Hematologic Splenic rupture, Leukocytosis
Respiratory Acute Respiratory Distress Syndrome (ARDS)
Vascular Capillary Leak Syndrome (CLS)

Researchers continue to monitor the overall long-term safety of pegfilgrastim use in this population.

Key Studies & References

  1. Pegfilgrastim versus filgrastim for prevention of chemotherapy-induced neutropenia: A meta-analysis of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Neulastim (FAQ)


Q: How is Neulastim different from other drugs for low white blood cells, like Neupogen?

A: Official information states that Neulastim (pegfilgrastim) is a pegylated version of filgrastim (the active ingredient in Neupogen). This modification allows Neulastim to stay in the body for a longer period of time. This long-acting design supports its typical administration as a single dose per chemotherapy cycle, whereas filgrastim products are often given via daily injections.


Q: How long do the side effects of Neulastim usually last?

A: Regulatory information indicates that many of the common, mild side effects, such as bone pain, are typically temporary. They often begin within a couple of days after the injection and may last for a few days to about a week. Patients are advised to report any side effects that are severe or persist to their healthcare provider.


Q: Can Neulastim be used for conditions other than cancer treatment?

A: Yes, regulatory documents approve Neulastim for more than one use. While it is primarily used to prevent infection after myelosuppressive chemotherapy, it is also indicated to increase survival in people exposed to severe radiation, which is known as the Hematopoietic Subsyndrome of Acute Radiation Syndrome.


Q: Can people with kidney problems use Neulastim?

A: The official product information does not usually recommend a specific dose change for patients with kidney impairment. However, reports of a type of kidney inflammation called glomerulonephritis have been associated with this class of medication. If a patient has an underlying kidney condition, they may require close monitoring by a healthcare professional.


Q: Can a child receive Neulastim?

A: Yes, Neulastim is approved for use in pediatric patients. For children weighing less than 45 kg, a dose based on their body weight is required. For children, the dose is determined by a healthcare provider based on the patient’s weight.


Q: Are there any long-term side effects associated with repeated Neulastim use?

A: Studies indicate that in patients with breast or lung cancer receiving chemotherapy and/or radiation, there is a risk of developing serious blood disorders, specifically Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). A healthcare professional weighs these potential long-term risks against the benefits of preventing severe infection.


Q: How quickly do my white blood cell counts return to normal after the Neulastim effect wears off?

A: The drug is designed to cause a significant, temporary spike in infection-fighting cells. The peak white blood cell count typically happens about 24 to 48 hours after the injection. Once the drug's effect is complete, the counts naturally begin to return to pre-treatment levels.


Q: Does Neulastim hurt when it's injected?

A: The official safety profile notes that pain, tenderness, or irritation at the injection site are reported side effects. Patients may also experience common systemic pain, such as bone pain, which often begins soon after the dose.


Q: How long after the injection does Neulastim start boosting my white blood cell count?

A: Neulastim begins working right after it is injected to stimulate the growth of new white blood cells. The peak concentration of these cells in the bloodstream is generally seen approximately 24 to 48 hours after the dose is given.


Q: Can Neulastim affect my appetite or make me feel tired?

A: Yes, regulatory documents list fatigue and loss of appetite (anorexia) as possible side effects associated with Neulastim use.


Q: What happens if I miss the specific window for the Neulastim injection?

A: The regulatory documents strictly warn against administering Neulastim during the window from 14 days before to 24 hours after cytotoxic chemotherapy. If administration is missed or mistimed, the official guidance is that the patient's healthcare professional must be contacted immediately for instruction on administering a replacement dose.


Q: Is there a version of Neulastim that doesn't require a shot?

A: No. Neulastim is a solution that must be given by subcutaneous injection (under the skin). This is typically done either with a prefilled syringe or through an on-body injector (OBI) device, which is applied to the skin and delivers the dose later.


Q: What are the signs of a severe allergic reaction to Neulastim that I should watch for?

A: Severe, life-threatening allergic reactions, including anaphylaxis, can occur with Neulastim. If a patient experiences any of these symptoms (such as a rash over the whole body, swelling around the mouth or eyes, difficulty breathing or wheezing, or a fast pulse), immediate emergency medical attention is needed.


Q: Is it true that Neulastim can sometimes cause spleen problems?

A: Official information includes a warning that splenic rupture (a severe injury to the spleen) has occurred in patients using G-CSF medicines like Neulastim, including fatal cases. Symptoms of this serious condition may include sudden pain in the upper left part of your abdomen or pain in the tip of your left shoulder.


Q: Are there generic versions or biosimilars of Neulastim available?

A: Yes. As a biologic drug containing pegfilgrastim, there are several FDA-approved biosimilars available. A biosimilar is a product that is highly similar to an already approved biologic medication, with no clinically meaningful differences in terms of safety and effectiveness.


Q: Why do doctors prescribe Neulastim for breast cancer patients?

A: Neulastim is indicated to reduce the risk of infection when patients are undergoing chemotherapy for non-myeloid cancers. The effectiveness and safety of this drug were established in key clinical trials involving breast cancer patients receiving chemotherapy that causes low white blood cell counts.


Q: Can Neulastim make my existing joint pain worse?

A: Bone pain and generalized musculoskeletal pain are very common and common side effects of Neulastim. If a patient has pre-existing joint pain, they should discuss any changes in their pain level with their healthcare provider.


Q: Can Neulastim interact with my heart or blood pressure medication?

A: Specific interaction studies with heart or blood pressure medications are not widely published in regulatory documents. However, a rare but serious condition called Aortitis (inflammation of the aorta, the body’s main artery) has been reported. Patients should ensure their healthcare provider is aware of all current medications, including those for the heart or blood pressure.


Q: Can I drink alcohol while I am being treated with Neulastim?

A: Official regulatory documents do not list any direct interactions between pegfilgrastim and alcohol. Patients are advised to consult their healthcare team regarding alcohol consumption during treatment.


Q: Does Neulastim protect against all types of infections?

A: Neulastim is a medicine that specifically increases the production of neutrophils, which are the type of white blood cells primarily focused on fighting bacterial infections. Its use is intended to reduce the risk of infection that leads to fever (febrile neutropenia).

How should Neulastim be stored and disposed of?

Neulastim (pegfilgrastim) must be stored properly to maintain its effectiveness. Always keep the medication in the refrigerator at 2^circmathrmC to 8^circmathrmC (36^circmathrmF to 46^circmathrmF) in its original carton to protect it from light. Do not freeze the prefilled syringe. If freezing occurs accidentally for a single period under 24 hours, thaw it in the refrigerator before use; discard it if it has frozen more than once.

Neulastim may be kept at room temperature (up to 25^circmathrmC or 30^circmathrmC depending on the product instructions) for a maximum single period of 48 to 72 hours. Any syringes left at room temperature for longer than this maximum time must be discarded. Do not shake the syringe vigorously.

Used prefilled syringes and needles must be immediately placed in an FDA-cleared sharps disposal container. Do not place these items in household trash or recycling containers. Dispose of the filled sharps container according to local regulations for hazardous waste, keeping it out of the reach of children.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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